(324 days)
The cCeLL - In vivo is an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues and is indicated for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection.
The cCeLL - In vivo is used to provide real-time endoscopic images of near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive, neurosurgery in adults.
The overall system includes a 6 mm Pixection ICG/NIR Endoscope (0°) for use in neurosurgery, a light source for emission of NIR illumination, a photo-multiplier tube capable of capturing NIR imaging, and a sterile probe sheath intended for maintaining a sterile barrier between the subject device and the patient. The cCeLL - In vivo can be used with any medical grade high definition (HD) monitor with a DVI-D or RGB input. The patient contacting components contact tissue or bone with a duration of less than 24 hours.
The provided text describes the cCeLL - In vivo device and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not include specific quantitative acceptance criteria or a dedicated study demonstrating the device meets those criteria in the typical sense of showing numerical thresholds for performance. Instead, the performance testing focuses on equivalence to a predicate device.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
The document describes various performance tests conducted to demonstrate the substantial equivalence of the cCeLL - In vivo device to its predicate. The "acceptance criteria" are implied to be achieving performance comparable to or equivalent to the predicate device, or meeting recognized safety and design specifications. The reported "device performance" is consistently "PASS" for all tests, indicating that the device met these implicit criteria of equivalence or specification conformance.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Image Sensitivity Analysis | Ability to visualize cerebral microstructures and vascular systems, including tumor tissue, surrounding normal tissue, and blood vessels using clinically relevant ICG concentrations. | PASS |
| Image Comparison Analysis | Visualize vessels of various sizes and changes in blood flow with image quality comparable to the predicate device. | PASS |
| Detection Linearity | Equivalent performance to the predicate device in capturing fluorescence intensity. | PASS |
| Geometric Distortion | Equivalent performance to the predicate device regarding geometric distortion. | PASS |
| Dynamic Range | Equivalent performance to the predicate device in gradation performance across its dynamic range. | PASS |
| Illumination & Detection Uniformity | Equivalent performance to the predicate device in illumination and detection uniformity (average intensity of fluorescent dots, illumination uniformity). | PASS |
| SNR & Sensitivity | Equivalent performance to the predicate device in signal-to-noise ratio (SNR) and sensitivity. | PASS |
| Video Latency | Equivalent performance to the predicate device in dynamic vision capability (initialization and stoppage of motion on screen). | PASS |
| Sterile Probe Sheath Tear Resistance | Withstand forces greater than those expected during clinical use for breaking strength at different joint interfaces on aged samples. | PASS |
| Electrical Safety / EMC | Conformity to IEC 60601-1:2005 + A1:2012 + A2:2021 and IEC 60601-1-2:2014 + A1:2020. | PASS |
| Software / Cybersecurity (Enhanced Level) | Conformity to FDA's "Content of Premarket Submissions for Device Software Functions" (June 14, 2023) and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Postmarket Management of Cybersecurity in Medical Devices". | PASS |
| Biocompatibility | Biocompatibility of patient-contacting components (Sterile Probe Sheath) according to FDA's guidance and ISO 10993-1 for various endpoints (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material medicated pyrogenicity, Hemocompatibility (indirect), Neurotoxicity). | PASS |
| Sterility / Shelf Life | Sterilization and shelf-life testing demonstrated the device is and can remain sterile and functional for the documented shelf life, conforming to ISO 11135:2014 + Amd1:2018, ASTM F1980-21, and ISO 11607–1:2019. | PASS |
Study Details for Performance Testing:
The document does not detail a single comprehensive "study" but rather a series of "Performance Testing" activities.
-
Sample size used for the test set and the data provenance:
- For "Image Sensitivity Analysis" and "Image Comparison Analysis," a "small animal model" was used. The exact number of animals is not specified.
- For other tests like Detection Linearity, Geometric Distortion, Dynamic Range, Illumination & Detection Uniformity, SNR & Sensitivity, and Video Latency, the tests were conducted using the subject and predicate devices, likely in a laboratory setting, without specific mention of "samples" in a patient data context.
- Data provenance is not explicitly stated as retrospective or prospective, or country of origin for the animal model. Given the context of equivalence testing against a predicate device, it is likely that these were controlled laboratory/pre-clinical tests.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the "Image Comparison Analysis," the results state: "as assessed across users with a range of experience." This implies human assessment, but the number of experts, their specific qualifications (e.g., radiologist with X years of experience), and how their input established ground truth are not specified.
- For all other tests, no experts were mentioned for establishing ground truth; the "ground truth" was likely defined by established physical properties or engineering measurements (e.g., optical power, brightness, tear resistance force).
-
Adjudication method for the test set:
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none). For the "Image Comparison Analysis" where "users with a range of experience" assessed images, the method of combining their assessments or resolving discrepancies is not provided.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The document describes performance testing for substantial equivalence, not a comparative effectiveness study involving human readers with and without AI assistance. The device is a medical imaging device, but the testing focuses on its technical performance and equivalence to a predicate, not on improving human reader performance.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device is described as an "optic scanner probe" and a "medical fluorescence imaging device." The tests described are primarily focused on the intrinsic technical performance of this imaging device (e.g., image sensitivity, detection linearity, dynamic range, SNR, video latency). While "Image Comparison Analysis" involved "users," most tests, particularly the quantitative ones, appear to be standalone algorithm/device performance tests. The device itself is an imaging tool, not one that implies an "algorithm only" component separate from the imaging hardware.
-
The type of ground truth used:
- For "Image Sensitivity Analysis" and "Image Comparison Analysis," the ground truth was inferred from the "visualization of cerebral microstructures and vascular systems" in a small animal model, which represents a biological/physiological ground truth.
- For other engineering-focused tests (Detection Linearity, Geometric Distortion, Dynamic Range, Illumination & Detection Uniformity, SNR & Sensitivity, Video Latency, Sterile Probe Sheath Tear Resistance, Electrical Safety / EMC), the ground truth would be based on physical measurements and established standards/specifications.
- For Biocompatibility and Sterility/Shelf Life, the ground truth is adherence to validated international standards and protocols.
-
The sample size for the training set:
- The document does not provide any information regarding a "training set" or "sample size for the training set." This suggests the device (cCeLL - In vivo) is an imaging system, likely based on established optical and fluorescence imaging principles, and not necessarily an AI/machine learning product that requires a distinct training dataset in the typical sense for its core functionality.
-
How the ground truth for the training set was established:
- Since no training set information is provided, this question is not applicable based on the given text.
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August 21, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
VPIX Medical, Inc. % Dawn N. Norman, M.S. Partner MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial, CO 80112
Re: K233391
Trade/Device Name: cCeLL - In vivo Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG, OWN Dated: July 18, 2024 Received: July 22, 2024
Dear Dawn Norman:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Adam D Pierce -S
Digitally signed by Adam D. Pierce -S Date: 2024.08.21 15:25:30 -04'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices
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OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K233391
Device Name cCeLL - In vivo
Indications for Use (Describe)
The cCeLL - In vivo is an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues and is indicated for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K233391 510(k) Summary
i. Submitter Information
ii.
iii.
| Submitter: | VPIX Medical, Inc. |
|---|---|
| 774, Gyeryong-ro, Jung-gu | |
| Daejeon, 34873 | |
| Republic of Korea | |
| Contact Person: | Kyungmin Hwang, President |
| Submitter: | Jin Hee Byon, RA Team Leader |
| Email: | julie.byon@vpixmedical.com |
| Phone: | +82 (0)42 535 0668 |
| Official Correspondent: | Dawn Norman, MS |
| Email: | dawn.norman@askmrcglobal.com |
| Phone: | 01-618-604-3064 |
| Date Prepared: | August 17, 2024 |
| Device Name | |
| Proprietary Name: | cCeLL - In vivo |
| Manufacturer: | VPIX Medical, Inc. |
| Common Name: | Neurological Endoscope |
| Classification Name: | Endoscope, Neurological |
| Regulation Number: | 21 CFR 882.1480; 21 CFR 876.1500 |
| Device Class: | Class II |
| Product Code: | GWG (Primary) |
| OWN (Secondary) | |
| Predicate Devices | |
| 510(k) Number: | K180146 |
| Proprietary Name: | KARL STORZ ICG Imaging System |
| Manufacturer | KARL STORZ Endoskopie-America, Inc. |
Manufacturer: Common Name: Classification Name: Regulation Number: Device Class: Product Code:
KARL STORZ Endoscopy-America, Inc. Neurological Endoscope Endoscope, Neurological 21 CFR 882.1480; 21 CFR 876.1500 Class II GWG, OWN
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iv. Device Description
The cCeLL - In vivo is used to provide real-time endoscopic images of near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive, neurosurgery in adults.
The overall system includes a 6 mm Pixection ICG/NIR Endoscope (0°) for use in neurosurgery, a light source for emission of NIR illumination, a photo-multiplier tube capable of capturing NIR imaging, and a sterile probe sheath intended for maintaining a sterile barrier between the subject device and the patient. The cCeLL - In vivo can be used with any medical grade high definition (HD) monitor with a DVI-D or RGB input. The patient contacting components contact tissue or bone with a duration of less than 24 hours.
V. Principle of Operation / Mechanism of Action
This product irradiates the tissue with a laser by contacting the probe to the suspected tumor site of a patient injected with indocyanine green. It is a medical fluorescence imaging device that measures the intensity of the fluorescence signal emitted from the tissue and images the cells of the tissue. It has a function to acquire an image of a part corresponding to an area of several hundred um of tissue at a depth of several to several hundred um by using fluorescence and shows a two-dimensional image through the provided software.
vi. Indications for Use
The cCeLL - In vivo is an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues and is indicated for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection.
vii. Summary of Substantial Equivalence
The similarities between subject device and predicate device are as follows: Both devices provide images of NIR Indocyanine green (ICG) dye fluorescence during minimally invasive, neurosurgery in adults.
Both can be used with any medical grade HD monitor with a DVI-D input.
The differences between subject device and predicate device are as follows:
The predicate also provides fluorescence during plastic, micro- and reconstructive surgical procedures in adults and pediatric populations. The predicate allows use of a medical grade HD monitor with 3G-SDI input. The predicate device is supplied with an ICG kit while the subject device is not.
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Substantial Equivalence Table:
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| 510(k) Number | K233391 | K180146 | N/A |
| DeviceIdentification | Trade Name: cCeLL - In vivoClassification Name: Neurological Endoscope | Trade Name: KARL STORZ ICG Imaging SystemClassification Name: Neurological Endoscope | N/A |
| Product Code | GWG, OWN | GWG, OWN | Identical |
| Regulation | 21 CFR 876.1480(Neurological Endoscope) | 21 CFR 876.1480(Neurological Endoscope) | Identical |
| DeviceDescription | The cCeLL - In vivo is used to provide real-timehigh-definition (HD) endoscopic images of near-infrared (NIR) indocyanine green (ICG) dyefluorescence during minimally invasive,neurosurgery in adults.The overall system includes a 6 mm PixectionICG/NIR Endoscope (0°) for use inneurosurgery, a light source for emission of NIRillumination, a photo-multiplier tube capable ofcapturing NIR imaging, and a sterile probesheath. | The KARL STORZ ICG Imaging System is used toprovide real-time high-definition (HD)endoscopic or telescopic images of visible (VIS)and near-infrared (NIR) indocyanine green (ICG)dye fluorescence during minimally invasive,neuro- and endonasal skull base surgery as wellas plastic, micro- and reconstructive surgicalprocedures in general and pediatric populations.The overall system includes a 4mm HOPKINSICG/NIR Endoscope (0°, 30° or 45°) for use inneuro- and endonasal skull base surgery, a 5mm& 10mm HOPKINS ICG/NIR Endoscope (0° or30°) for use in minimally invasive proceduresand a VITOM II ICG/NIR Telescope for use inplastic, micro- and reconstructive surgicalprocedures for VIS and NIR illumination andimaging, a light source with foot switch foremission of VIS and NIR illumination, a colorvideo camera head capable of capturing bothVIS and NIR imaging, and a KARL STORZ ICG Kit.Additional accessories used with the KARLSTORZ ICG Imaging System include twostandards fiber-optic light cables fortransmission of VIS and NIR light and theImage1 S Camera Control Unit (CCU). | SimilaritiesBoth devices provide HDimages of NIRIndocyanine green (ICG)dye fluorescence duringminimally invasive,neuro- and endonasalskull base surgery inadults.Both can be used withany medical grade HDmonitor with a DVI-Dinput.DifferencesThe predicate alsoprovides fluorescenceduring plastic, micro-and reconstructivesurgical procedures inpediatric populations.The predicate allows useof a medical grade HDmonitor with 3G-SDIinput. |
| Subject Device | Predicate Device | Comparison | |
| The cCeLL - In vivo can be used with anymedical grade HD monitor with a DVI-D or RGBinput. | The KARL STORZ ICG Imaging System can beused with any medical grade HD monitor with aDVI-D or 3G-SDI input. | The predicate device issupplied with an ICG kitwhile the subject deviceis not. | |
| Intended Use | The cCeLL - In vivo is intended to provide real-time near-infrared fluorescence imaging. | The KARL STORZ ICG Imaging System is intendedto provide real-time visible and near-infraredfluorescence imaging. | Identical except thepredicate providesvisible fluorescenceimaging. |
| Indications forUse | The cCeLL - In vivo is an optic scanner probeplaced in direct contact with tissue to createimages of the internal microstructure of tissuesand is indicated for use with indocyanine green(ICG) for fluorescence imaging as an aid in thevisualization of vessels (micro- and macro-vasculature) blood flow in thecerebrovasculature before, during or aftercranial diagnostic and therapeutic procedures,such as tumor biopsy and resection. | The KARL STORZ Endoscopic ICG System enablessurgeons to perform minimally invasive surgeryusing standard endoscopic visible light as well asvisual assessment of vessels, blood flow andrelated tissue perfusion, or at least one of themajor extra-hepatic bile ducts (cystic duct,common bile duct and common hepatic duct),using near infrared imaging. Fluorescenceimaging of biliary ducts with the KARL STORZEndoscopic ICG System is intended for use withstandard of care white light and, whenindicated, intraoperative cholangiography. Thedevice is not intended for standalone use forbiliary duct visualization. | SimilaritiesBoth use HD images ofNIR Indocyanine green(ICG) dye fluorescenceduring minimallyinvasive, neuro- andendonasal skull basesurgery in adults.Both can be used withany medical grade HDmonitor with a DVI-Dinput. |
| Additionally, the KARL STORZ Endoscopic ICGSystem enables surgeon to perform minimallyinvasive cranial neurosurgery in adults andpediatrics and endonasal skull base surgery inadults and pediatrics > 6 years of age usingstandard endoscopic visible light as well asvisual assessment of vessels, blood flow andrelated tissue perfusion using near infraredimaging.The KARL STORZ VITOM II ICG System isintended for capturing and viewing fluorescentimages for the visual assessment of blood flow, | DifferencesThe predicate isindicated for pediatricscranial neurosurgery andendonasal skull basesurgery in adults andpediatrics > 6 years ofage.The predicate hasmultiple light andvisualization options.The predicate also | ||
| as an adjunctive method for the evaluation of | The predicate also | ||
| Subject Device | Predicate Device | Comparison | |
| tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light. | provides fluorescence during plastic, micro- and reconstructive surgical procedures in general and pediatric populations.The predicate allows use of a medical grade HD monitor with 3G-SDI input. | ||
| The cCeLL - In vivo includes the following components and accessories: | The KARL STORZ ICG Imaging System includes the following components and accessories: | SimilaritiesBoth devices use a camera and optical fiber light source to process images. | |
| Main Unit(for NIR illumination and capturing) Pixection (for endoscope) Sterile Probe Sheath | 4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes VITOM II ICG Telescope Camera Head (H3Z-FI) Fiber optic Light Cables Light Source Image1 S CCU | ||
| TechnologicalCharacteristics | The Pixection is intended to be connected to the Main Unit, which connects to the PC for image processing, as well as to the light source via optical fiber as the source of illumination to allow visualization of internal anatomy. Visualization and navigation is performed using NIR imaging for visual assessment and/or confirmation of vessels, blood flow or tissue perfusion is desired. | The endoscopes/telescope are intended to be connected to the optical coupler of the camera head, which connects to the CCU for image processing, as well as to the light source via compatible light cable as the source of illumination to allow visualization of internal anatomy. Visualization and navigation is performed initially using VIS imaging. NIR imaging is selected when visual assessment and/or confirmation of vessels, blood flow or tissue perfusion is desired. | DifferencesThe predicate uses VIS while the subject device uses NIR for Visualization and navigation. |
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viiii. Performance Testing
Verification and validation testing demonstrated that the subject device conforms to the recognized safety standards, design input specifications and intended use consistent with the predicate device.
| Test | Test Method Summary | Results |
|---|---|---|
| Image SensitivityAnalysis | Validate the device's ability to visualize cerebral microstructures andvascular systems, including tumor tissue, surrounding normal tissue, bloodvessels using clinically relevant ICG concentrations in a small animal model. | The study confirmed that the device effectivelyvisualized cerebral microstructures and vascularsystems across a range of clinically relevant ICGconcentrations. PASS |
| ImageComparisonAnalysis | Comparison of the fluorescence signal between the subject and predicatedevice, following ICG injection in a small animal model, was conducted todetermine if the subject device performs equivalently to the predicatedevice in visualizing vessels of various sizes and changes in blood flow. | The study confirmed that the subject device canvisualize vessels of various sizes and changes inblood flow with image quality comparable to thepredicate device, as assessed across users with arange of experience. PASS |
| DetectionLinearity | To verify the device's accuracy and reliability in capturing fluorescenceintensity, detection linearity was assessed by measuring optical power andbrightness at various increments for both the predicate and subjectdevices. | The detection linearity test demonstratedequivalent performance to the predicate device.PASS |
| GeometricDistortion | To verify the device's accuracy and reliability in capturing fluorescenceintensity with respect to geometric distortion, the power was measuredusing an optical power meter and radial distortion was calculated from theacquired image. Performance testing conducted with the predicate andsubject devices. | The geometric distortion test demonstratedequivalent performance to the predicate device.PASS |
| Dynamic Range | To verify the device's gradation performance in capturing fluorescenceintensity across its dynamic range, optical power and brightness were set,fluorescent target removed and the dynamic range was calculated usingthe acquired image. Performance testing conducted with the predicate andsubject devices. | The dynamic range test demonstrated equivalentperformance to the predicate device. PASS |
| Illumination &DetectionUniformity | To verify the device's accuracy and reliability in capturing fluorescenceintensity, illumination and detection uniformity, the average intensity ofeach fluorescent dot in the region of interest [diagnostic area] and the | Testing measuring illumination and detectionuniformity demonstrated equivalent performanceto the predicate device. PASS |
| Test | Test Method Summary | Results |
| illumination uniformity were calculated using the acquired image.Performance testing conducted with the predicate and subject devices. | ||
| SNR &Sensitivity | To verify the device's sensing ability in capturing fluorescence intensity,images were acquired and the signal to noise ratio (SNR) and sensitivitywere calculated. Performance testing conducted with the predicate andsubject devices. | SNR & sensitivity test demonstrated equivalentperformance to the predicate device. PASS |
| Video Latency | To verify the device's dynamic vision capability in capturing fluorescenceintensity, video latency was assessed by recoding the initialization andstoppage of motion on the screen and calculating the latency. Performancetesting conducted with the predicate and subject devices. | The test results demonstrated equivalentperformance to the predicate device.PASS |
| Sterile ProbeSheath TearResistance | To verify the robustness of SPS (Sterile Probe Sheath) tear resistance of theSPS was tested for breaking strength at different join interfaces on agedsamples. | The test resutls demonstrated that the SPS canwithstand forces greater than those expectedduring clinical use. PASS |
| Electrical Safety/ EMC | IEC 60601-1:2005 + A1:2012 + A2:2021 Medical electrical equipment – Part1: General requirements for basic safety and essential performanceIEC 60601-1-2 : 2014 + A1:2020, Medical Electrical Equipment - Part 1-2:General requirements for basic safety and essential performance -Electromagnetic Compatibility | PASS |
| Software /Cybersecurity(Enhanced Level) | FDA's Guidance for Industry and FDA Staff, "Content of PremarketSubmissions for Device Software Functions" issued June 14, 2023.FDA guidance's Cybersecurity in Medical Devices: Quality SystemConsiderations and Content of Premarket Submissions, PostmarketManagement of Cybersecurity in Medical Devices. | PASS |
| Biocompatibility | Per FDA's Guidance "Use of International Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process", the single use Sterile Probe Sheath (SPS) iscategorized as an external communicating device in contact withtissue/bone/dentin for <24 hours. | Biocompatibility testing in accordance with FDA'sbiocompatibility guidance demonstrated that thepatient-contacting components arebiocompatible. PASS |
| Test | Test Method Summary | Results |
| The following biocompatibility endpoints were evaluated: | ||
| CytotoxicitySensitizationIntracutaneous reactivityAcute systemic toxicityMaterial medicated pyrogenicityHemocompatibility (indirect)Neurotoxicity | ||
| Sterility / ShelfLife | ISO 11135:2014 + Amd1:2018 Sterilization of health care product –Ethylene Oxide – Requirements for development, validation and routinecontrol of a sterilization process for medical devices | Sterilization and shelf-life testing of the SterileProbe Sheath (SPS) demonstrated the device isand can remain sterile and functional for thedocumented shelf life. PASS |
| ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile BarrierSystems and Medical Devices | ||
| ISO 11607–1:2019 Packaging for terminally sterilized medical devices - Part1: Requirements for materials, sterile barrier systems and packagingsystems were used to validate the shelf life. |
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ix. Conclusion
Based on the similarities of the indications for use, device design, principles of operation, technological characteristics and the results of the non-clinical performance testing, the substantially equivalent to the legally marketed predicate device and does not raise new concerns of safety and effectiveness.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).